Device for providing spongy bone with bone substitute and/or bone reinforcing material, bone substitute and/or bone reinforcing material and method

ABSTRACT

The present invention relates to a device for providing spongy bone with bone substitute and/or bone reinforcing material, wherein at least one perforating device ( 4 ) is provided for making at least one hole ( 5 ) in the spongy bone ( 1 ) and wherein at least one flushing or rinsing device ( 6 ) is provided for flushing or rinsing the hole ( 5 ) with a rinsing agent ( 7 ). At least one vacuum source ( 9 ) is provided for generating a vacuum in the hole ( 5 ) in the spongy bone ( 1 ) for sucking and/or facilitating insertion or feeding of the bone substitute and/or bone reinforcing material ( 3 ) into said spongy bone ( 1 ). The invention also relates to bone substitute and/or bone reinforcing material and methods in connection with the invention.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a divisional of application Ser. No. 10/578,734,filed May 10, 2006, allowed Jul. 27, 2010, which is a National StageEntry of PCT International Application No. PCT/SE2004/001626, filed Nov.10, 2004, which claims the benefit of priority of Swedish ApplicationNo. 0302983-2, filed Nov. 11, 2003. All of the above listed applicationsare hereby incorporated by reference in their entirety.

FIELD OF THE INVENTION

The present invention relates to a device for providing spongy bone withbone substitute and/or bone reinforcing material, wherein at least oneperforating device is provided for making at least one hole in thespongy bone and wherein at least one flushing or rinsing device isprovided for flushing or rinsing the hole with a rinsing agent. Theinvention further relates to a bone substitute and/or bone reinforcingmaterial and a method.

BACKGROUND OF THE INVENTION

Vertebroplasty is a technique according to which biocompatible materialis injected into a spongy vertebra. After some time, the injectedmaterial hardens, whereby an inner support is obtained for fixing thevertebra and thereby alleviate pain and reduce the risk of vertebralcollapse.

The material is injected into the vertebra through a needle and in doingso, it is necessary to subject the material to high pressure, often oneor more MPa. Hereby, there is an obvious risk that tissue material, e.g.blood and fat, in the vertebra is pressed out into the blood vessels orinto fracture gaps such that said material can affect adjacent nerves.There is also an obvious risk that the injected material is pressed outinto fracture gaps or into adjacent tissue. This is well known and thematerial and fat being pressed out can reach the blood vessels and thelungs, resulting in a poorer oxygenation, blood pressure reduction and,in exceptional cases, death.

By inserting an extra needle into the vertebra, the risk of leakage(note publications in the enclosed reference list, point 1 and 2, in theend of the description). Normally, this extra needle is left open orpreferably connected to a suction hose for generating a suction effect(note publication in the enclosed reference list, point 3). However, anydecisive effect is not reached with the prior art.

Various hole making and rinsing devices for making holes in and rinsingof vertebrae are known from e.g. U.S. Pat. No. 6,440,138, U.S. Pat. No.6,716,216, U.S. Pat. No. 6,719,761 and U.S. Pat. No. 6,740,090, but noneof these publications describes generation of a vacuum in the vertebraefor providing safe suction of bone substitute and/or bone reinforcingmaterial into said vertebrae.

SUMMARY OF THE INVENTION

The object of the present invention has been to eliminate theabovementioned problem and this is arrived at while the invention hasbeen given the characterizing features of each of the subsequent claims.

By making a hole in the spongy bone and rinse it, tissue material andother material can be flushed away from the hole and the sides thereof,such that said sides get rough or uneven surfaces with depressions intowhich the bone substitute and/or bone reinforcing material can bebrought to penetrate by generating a vacuum in the hole and withoutrisking that said bone substitute and/or bone reinforcing materialpenetrates into the blood paths.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention will be further described below with reference to theaccompanying drawings, in which:

FIG. 1 is a schematic view of a device according to the invention whenmaking a hole in a spongy vertebra shown in section;

FIG. 2 illustrates parts of the device of FIG. 1 during flushing orrinsing of the hole made in the spongy vertebra;

FIG. 3 illustrates parts of the device according to the invention duringsuction of bone substitute and/or bone reinforcing material into thevertebra;

FIG. 4 is a sectional view of a spongy vertebra in which bone substituteand/or bone reinforcing material has been injected with pressure througha needle according to prior art; and

FIG. 5 is a sectional view of a spongy vertebra into which bonesubstitute and/or bone reinforcing material has been sucked by means ofa device according to the invention.

In the figures, different parts of a device for preparing spongy bone 1,e.g. a vertebra 2, to receive bone substitute and/or bone reinforcingmaterial 3, and for locating said material in said vertebra isschematically illustrated. Said device comprises at least oneperforating device 4 for making at least one hole 5 in the vertebra 2,at least one flushing or rinsing device 6 for flushing or rinsing saidhole with rinsing agent 7 and at least one supply device 8 which permitssuction and/or insertion of bone substitute and/or bone reinforcingmaterial 3 into the vertebra.

At least one vacuum source 9 is provided to generate a vacuum in thehole 5 in the vertebra 2 for sucking and/or facilitate insertion of bonesubstitute and/or bone reinforcing material 3 into said vertebra.

The perforating device 4 can be designed in many different ways and socan also the rinsing device 6. At the exemplary embodiment of FIGS. 1and 2, the perforating and rinsing devices 4, 6 are combined to a device10 including an outer tube member 11 which can be located at thevertebra 2. In the tube member 11 there is provided a perforating means12 which is movable relative to said tube member in coaxial and/orrotary direction. The perforating means 12 has and/or cooperates with aperforating member 13 which can be designed in many ways. As an exampleof a perforating member 13, it is shown an end portion of theperforating means 12 which can be retracted into the outer tube member11 when this is located at the vertebra 2 and which is bent when it isexpelled out of said pipe member. When the perforating means 12 isrotated, the bent perforating member 13 will make the hole 5 in thevertebra 2.

The movements of the perforating means 12 can be obtained by means of adrive unit 14 of a suitable type.

At the exemplary embodiment, the perforating means 12 is designed as aninner tube member 15. A rinsing agent container 16 is connected to thisinner tube member 15 through a connecting device 17 which permitsfeeding of rinsing agent 7 from the container 16 into the inner tubemember 15 irrespective of whether said inner tube member is rotatable ornot. Alternatively, the rinsing agent container 16 may be connected tothe outer tube member 11 and the collecting device 27 and the vacuumsource 9 to the inner tube member 15, such that the outer tube member 11can lead rinsing agent 7 into the hole 5 and be sucked out of said holethrough the inner tube member 15. The perforating device 4 is usedpreferably for making at least two holes 5 in the vertebra 2. Theseholes 5 are located such that they communicate with each other either byextending into each other (as is illustrated in FIG. 3) or by havingspongy bone 1 between them since such bone is pervious to air and can beprovided with bone substitute and/or bone reinforcing material 3.

The vacuum source 9 is provided to suck rinsing agent 7 through the hole5 and it is preferably connected to the outer tube member 11 forsucking, through said outer tube member, rinsing agent 7 and tissuematerial and other material out of said hole 5.

Between the outer tube member 11 and the vacuum source 9 there ispreferably a collecting device 27 for collecting rinsing agent 7 andtissue material and other material brought along therewith out of thehole 5.

The rinsing device 6 is preferably provided also to flush or rinse thesides 5 a of the hole 5 such that depressions 5 b and similar are formedtherein while tissue material and other material is flushed off saidsides. This is advantageous since bone substitute and/or bonereinforcing material 3, by means of the vacuum generated in the hole 5,can be brought to penetrate into the depressions 5 b.

At the embodiment illustrated in FIG. 3, the outer tube member 11 hasits equivalent in a first cannula or needle 19 which can cooperate witha perforating device (not shown) for making a first hole 5 in thevertebra 2. A second cannula or needle 20 is connected to a vacuumsource 9 and this second cannula can also cooperate with a perforatingdevice (not shown) for making a second hole 5 in the vertebra 2.

The supply device 8 illustrated in FIG. 3 may have a container 18 formixing various components for production of bone substitute and/or bonereinforcing material 3 and/or for storage thereof. The container 18 isconnected or connectable to a first cannula or needle 19 which can beinserted into the vertebra 2 and which is adapted to lead bonesubstitute and/or bone reinforcing material 3 into the holes 5 in thevertebra 2. A second cannula or needle 20 can be inserted into thevertebra 2 and is connected to the vacuum source 9, which is adapted togenerate a vacuum in the holes 5 such that bone substitute and/or bonereinforcing material 3 is sucked into said holes and/or for facilitatinginsertion or feeding of said material into said holes.

The vacuum source 9 can be an injector pump 21 which is run or driven bya suitable compressed medium from a compressed-medium device 22. Theinjector pump 21 may e.g. be driven by compressed air and connected,through a compressed-air conduit 23, to a compressed-medium device 22 inthe form of a compressed-air device. This device may be built into ahospital or other locality in which the injector pump 21 shall be used.Alternatively, the injector pump 21 can be run or driven by anothercommercially available gas as is indicated with broken lines in FIG. 3.

The compressed-medium device 22 can operate the injector pump 21 with acompressed-medium pressure of 4, 5-8, 5 bar and the injector pump 21 maybe of a type which is placed on the floor and which has a foot pedal 24for its operation. Thus, the injector pump 21 can be started by tiltingthe foot pedal 24 in one direction and stopped by tilting the foot pedal24 in the opposite direction. As an example of a usable injector pump 21in this connection one can mention an injector pump of the type used forproducing bone cement as defined in U.S. patent specification U.S. Pat.No. 5,328,262 and sold under the product name Scan Vacuum Pump™ by thecompany Scandimed International AB, Sjobo, Sweden.

The injector pump 21 is preferably provided to generate a vacuum in allthe holes 5 of the spongy bone 1 such that said holes are filled or canbe filled with bone substitute and/or bone reinforcing material 3 and/ora vacuum such that the bone substitute and/or bone reinforcing material3 is distributed therein, preferably without any or any substantialportions thereof being sucked into the second cannula 20.

The injector pump 21 can be provided to generate a vacuum of between −0,5 bar and −0, 92 bar in the spongy bone 1, which vacuum corresponds to a70% and 90% absolute vacuum. In many cases it is sufficient that theinjector pump 21 generates a vacuum of between −0, 7 bar and −0, 8 barin the spongy bone 1.

The injector pump 21 is preferably provided to suck tissue material suchas blood and fat out of the holes 5 of the spongy bone 1 and into thesecond cannula 20 before bone substitute and/or bone reinforcingmaterial 3 is sucked into the spongy bone 1 through the first cannula19.

In at least one connecting conduit 25 between the second cannula 20 (theinlet end of which is the end which is inserted into a hole 5 of thespongy bone 1) and the injector pump 21, there may be provided anon-return valve device 26 and/or a collecting device 27 and/or amonomer filter 28 (if the bone substitute and/or bone reinforcingmaterial 3 is of bone cement type) and/or a bacteria filter 29.

The collecting device 27 may be a container which is placed on the floorand closed or sealed by means of a cap. A portion of the connectingconduit 25, which is connected to the second cannula 20, is directedthrough the cap and a small distance down into the container. Anotherportion of the connecting conduit 25 is also directed through the capand a small distance down into the container. When tissue material issucked from the holes 5 of the spongy bone 1 to the collecting device27, said material is collected down below in the container and istherefore prevented from being sucked further towards the injector pump21 and into said pump. If there is a monomer filter 28 and/or a bacteriafilter 29 between the collecting device 27 and the injector pump 21, thetissue material is prevented also from being sucked thereto.

The monomer filter 28 may be a carbon filter and is adapted to preventmonomer gases, generated during production of bone substitute and/orbone reinforcing material 3 in the form of bone cement, from beingsucked into the injector pump 21 and discharged to the surroundings. Theadvantages with such a monomer filter 28 are described in thepublication according to the enclosed reference list, point 4. Thebacteria filter 29 is provided to prevent bacteria from entering orgetting into the holes 5 of the spongy bone 1 if the connecting conduit25 is opened or opens unintentionally and air is sucked therethrough tothe holes 5 if there is a vacuum therein.

The monomer filter 28 and bacteria filter 29 may be provided in thatportion of the connecting conduit 25 which connects the collectingdevice 27 with the injector pump 21.

The non-return valve device 26, which preferably can be provided in theconnecting conduit 25 between the collecting device 27 and the secondcannula 20, is adapted to prevent tissue material from being sucked outof the collecting device 27 and into the holes 5 of the spongy bone 1 ifthe connecting conduit 25 is opened or opens unintentionally such that asuction is generated therein towards the holes 5 of the spongy bone 1 ifthere is a vacuum therein.

The container 18 may include a feeding device 30 for feeding bonesubstitute and/or bone reinforcing material 3 out of the container 18and into the holes 5 of the spongy bone 1 at the same time the injectorpump 21 generates a vacuum therein or thereafter.

The feeding device 30 is schematically illustrated with a feed means 31which is displaceably mounted relative to the container 18 and which canbe displaced manually for discharge of bone substitute and/or bonereinforcing material 3 from the container 18 and through the firstcannula 19 into the holes 5 of the spongy bone 1.

The container 18 may eventually be used as mixing container for mixingthe components required for the production of such bone substituteand/or bone reinforcing material 3 that can be brought to harden afterinsertion thereof into the holes 5 of the spongy bone 1. This mixing canoccur with a mixing means or in any other way. Such a mixing means canpreferably be moved manually back and forth in the container 18 and iseventually rotated relative thereto for mixing the components.

A valve device 32 may be provided for, on one hand, close or interruptthe supply of bone substitute and/or bone reinforcing material 3 throughthe first cannula 19 to the holes 5 of the spongy bone 1 until theinjector pump 21 has generated a suitable vacuum therein. When this isdone, the valve device 32 may be opened for permitting suction of bonesubstitute and/or bone reinforcing material 3 into the holes 5 of thespongy bone 1 by means of the injector pump 21. The valve device 32 maybe located on the first cannula 19 or on a connecting conduit betweenthe container 18 and the first cannula 19. The valve device 32 may bemanually operable by means of a control handle 33.

As an alternative to the embodiment of the flushing or rinsing device 6described above, said device may be combined with the supply device 8.At this alternative, the rinsing agent container 16 of the rinsingdevice 6 may be connected to the first cannula 19 e.g. through the valvedevice 32 which in this case can be a three way valve permitting eitherthat the supply of rinsing agent to the vertebra 2 is open and thesupply of bone substitute and/or bone reinforcing material 3 to thevertebra 2 is closed or that said supply of rinsing agent is interruptedand said supply of material open.

The rinsing agent 7 may be of different types and it may e.g. bedistilled water or a sodium chloride solution and/or be detergent and/orinclude at least one trombolytic substance, e.g. heparin, streptokinase,urokinase, TPA and/or other substances dissolving coagulum and thrombi.

The bone substitute and/or bone reinforcing material 3 may consist ofprimarily minerals or ceramics which can be mixed with a hardener, e.g.water. These substances may be selected from the group comprisingcalcium sulphate-α-hemihydrate, calcium sulphate-β-hemihydrate, calciumsulphate-dihydrate, calcium carbonate, a-tricalcium phosphate,hydroxyapatite, dicalcium phosphate-dihydrate, anhydrous dicalciumphosphate, tetracalcium phosphate, β-tricalcium phosphate, calciumdeficient hydroxyapatite, monocalcium phosphate-monohydrate, monocalciumphosphate, calcium-pyurophosphate, precipitated hydroxyapatite,carbonaceous apatite (dahlite), octacalcium phosphate, amorphous calciumphosphate, oxyapatite, carbonato apatite and calcium aluminate.

A ceramic material may be calcium aluminate, which forms part of theproduct Doxa T from the company Doxa (www.doxa.se/pdf/nyhet_(—)1.pdf).

X-ray contrast agents can be added to said ceramic bone substituteand/or bone reinforcing material 3, e.g. water soluble non-ionic X-raycontrast agents selected from the group comprising iohexol, ioversol,iopamidol, iotrolan, metrizamide, iodecimol, ioglucol, ioglucamide,ioglunide, iogulamide, iomeprol, iopentol, iopromide, iosarcol,iosimide, iotusal, ioxilan, iofrotal and iodecol.

Alternatively, the bone substitute and/or bone reinforcing material 3can be a hardenable bone cement comprising polymer and monomercomponents. The polymer may be polymethylmethacrylate (PMMA) and themonomer methylmethacrylate (MMA). A polymer base material can be theproduct Cortoss™ from the company Orthovita in the U.S. For compositionsee www.orthovita.com/products/cortoss/oustechspecs.html. Anotherpolymer base material can be the product SECOUR® Acrylic Resin PMMA fromparallax medical inc.(www.parallax-medical.com/go/9192b550-56421157-a432-d7a2b98310fe).

The bone substitute and/or bone reinforcing material 3 may consist of amineral and/or a ceramic in combination with polymer material.

The advantages with the invention is obvious when comparing the degreeor ratio of fullness of the vertebra 2 of FIGS. 4 and 5. In the vertebra2 of FIG. 4, the bone substitute and/or bone reinforcing material 3 hasbeen pressed into said vertebra 2 through a cannula or needle and itclearly appears from FIG. 4 that only a part of the vertebra 2 is filledwith bone substitute and/or bone reinforcing material 3. In the vertebra2 of FIG. 5 however, the bone substitute and/or bone reinforcingmaterial 3 has been sucked into the vertebra 2 in accordance with theinvention through the cannula or needle and it is clearly evident fromFIG. 5 that substantially larger parts of the vertebra 2 are filled withbone substitute and/or bone reinforcing material 3 without said materialhaving been pressed out into the blood paths.

It is also obvious from FIG. 5 that the negative pressure generated bythe vacuum source 9 has provided for a uniform and complete distributionof the bone substitute and/or bone reinforcing material 3 in the hole 5and depressions 5 b in the sides 5 a of the hole 5.

The invention is not limited to what is described above and illustratedin the drawings, but may vary within the scope of subsequent claims.Thus, the vacuum source 9 may instead of an injector pump 21 be anothervacuum pump which can be electrically operated or operated by gas or byhand or operated in any other way, that the hole 5 may be more than onehole and surrounding parts thereto, that the rinsing agent 7 may beanother than those described and that the bone substitute and/or bonereinforcing material 3 may be of another type than those described.

There may be a device for imparting pulse like suction and/or insertionmovements to the bone substitute and/or bone reinforcing material 3 intothe hole(s) 5 in the spongy bone 1. Furthermore, there may be a devicefor imparting reciprocating suction and/or insertion movements to thebone substitute and/or bone reinforcing material 3 into the hole(s) 5 inthe spongy bone 1.

There may also be a device for pulse like suction and/or feeding of therinsing agent 7 through the hole(s) 5 in the spongy bone 1.

Said device may be defined by pulsating the vacuum source 9 and/or itsvacuum generation and/or by generating pulses by means of the feedingdevice 30.

REFERENCE LIST

1) Aebli Nt Krebs J, Schwenke D, Davis G, Theis J C. Cardiovascularcharges during multiple vertebroplasty with and without vent-hole: anexperimental study in sheep. Spine 2003;28(14):1504-11.2) Koessler M J, Aebli N, pitto R P. Fat and Bone Marrow Embolism DuringPercutaneous Vertebroplasty. Anesth Analg 2003;97:293-294.3) Lidgren, Lars. Bone Substitutes. Karger Gazette No. 65 2003; Bone andJoints.4) Kirby B S, Doyle A, Gilula L A. Acute bronchospasm due to exposure topolymethacrylate vapours during percutaneous vertebroplasty. AJR JRoentgenol. 2003 Feb; 180 (2) :543-4.

1. A device for providing spongy bone with bone substitute and/or bonereinforcing material, including: at least one perforating device (4)configured to make at least one hole (5) in the spongy bone (1), atleast one flushing or rinsing device (6) configured to flush or rinsethe hole (5) with a rinsing agent (7), at least one supply device (8)configured to supply the bone substitute and/or bone reinforcingmaterial (3) to the hole (5) in the spongy bone (1), and at least onevacuum source (9) configured to generate a vacuum in the hole (5) in thespongy bone (1), suck the rinsing agent (7) into the hole (5) in thespongy bone(1), and to suck rinsing agent (7) and tissue material out ofthe hole (5), wherein said vacuum source (9) is further configured tosuck the bone substitute and/or bone reinforcing material (3) into thehole (5) in the spongy bone (1), and wherein the perforating devicecomprises an outer tube (11) and an inner tube (15).
 2. (canceled) 3.The device according to claim 1, wherein the vacuum source (9) isprovided to generate a vacuum in the hole (5) of the spongy bone (1)which is adapted such that the bone substitute and/or bone reinforcingmaterial (3) is sucked into said hole (5) and distributed thereinwithout substantial portions thereof being sucked out of the hole (5).4. The device according to claim 1, wherein the vacuum source (9) isprovided to suck tissue material out of the hole (5) of the spongy bone(1) before bone substitute and/or bone reinforcing material (3) issucked into the spongy bone (1).
 5. The device according to claim 1,further comprising a collecting device (27) configured to collect tissuematerial which by the vacuum source (9) has been sucked out of the hole(5) of the spongy bone (1) for preventing tissue material from beingsucked into the vacuum source (9) and/or into a monomer filter (28)and/or into a bacteria filter (29).
 6. The device according claim 1,further comprising a monomer filter (28) configured to prevent poisonousgases, which are generated during production of bone substitute and/orbone reinforcing material (3) from being discharged into thesurroundings.
 7. The device according to claim 1, further comprising abacteria filter (29) configured to prevent bacteria from getting intothe hole (5) of the spongy bone (1) if a connection between the vacuumsource (9) and the spongy bone (1) is opened unintentionally.
 8. Thedevice according to claim 1, further comprising a non-return valvedevice (26) configured to prevent tissue material and/or any othermaterial and/or bacteria from being sucked into the hole (5) of thespongy bone (1) if the connection between the vacuum source (9) and thehole (5) in the spongy bone (1) is opened unintentionally.
 9. The deviceaccording to claim 5, further comprising a non-return valve device (26)configured to be located between the hole (5) in the spongy bone (1) andthe collecting device (27).
 10. The device according to claim 5, furtherincluding a non-return valve device (26) configured to be locatedbetween the monomer filter (28) and/or the bacteria filter (29) and thehole (5) in the spongy bone (1).
 11. The device according to claim 1,further comprising a container (18) configured to produce and/or storebone substitute and/or bone reinforcing material (3), wherein thecontainer includes a feeding device (30) configured to feed bonesubstitute and/or bone reinforcing material (3) out of the container(18) and into the hole (5) of the spongy bone (1) at the same time thevacuum source (9) generates a vacuum therein.
 12. The device accordingto claim 1, further comprising a container (18) configured to produceand/or store bone substitute and/or bone reinforcing material (3),wherein the container (18) includes a feeding device (30) configured tofeed bone substitute and/or bone reinforcing material (3) into the hole(5) of the spongy bone (1) after the vacuum source (9) has generated avacuum therein.
 13. The device according to claim 11, wherein thefeeding device (30) is manually operable.
 14. The device according toclaim 1, wherein the vacuum source (9) is configured to generate avacuum of between −0.5 bar and −0.92 bar in the hole (5) of the spongybone (1).
 15. The device according to claim 14, the vacuum source (9) isconfigured to generate a vacuum of between −0.7 and −0.8 bar in the hole(5) of the spongy bone (1).
 16. The device according to claim 1, furthercomprising a valve device (32) configured to close or interrupt thesupply of bone substitute and/or bone reinforcing material (3) to thehole (5) of the spongy bone (1) until the vacuum source (9) hasgenerated a suitable vacuum therein, the valve device (32) beingconfigured to open and permit supply of bone substitute and/or bonereinforcing material (3) such that said material is sucked into the hole(5) of the spongy bone (1) when said suitable vacuum has been measuredtherein.
 17. The device according to any claim 1, further comprising atleast a first cannula or needle and a second cannula or needle (19, 20)configured to be insertable into the spongy bone (1) such that they aresimultaneously directed into the hole (5) thereof, wherein the firstcannula or needle (19) is connected to a container (18) for producingand/or storing the bone substitute and/or bone reinforcing material (3)while the second cannula or needle (20) is connected to the vacuumsource (9).
 18. The device according to claim 17, wherein the flushingor rinsing device (6) comprises a rinsing agent container (16) which isconnected to the first cannula or needle (19) for leading rinsing agent(7) into the hole (5) of the spongy bone (1) through said first cannula(19) and out of said hole (5) to the second cannula or needle (20). 19.The device according to claim 18, further comprising a valve device (32)configured to either open for supply of bone substitute and/or bonereinforcing material (3) or of rinsing agent (7) through the firstcannula or needle (19).
 20. The device according to claim 1, wherein therinsing device (6) is configured to flush or rinse the sides (5 a) ofthe hole (5) so that tissue material and other material are flushed awaytherefrom such that depressions (5 b) are formed therein, into which thebone substitute and/or bone reinforcing material (3) can penetrate. 21.(canceled)
 22. (canceled)
 23. The device according to claim 1, whereinthe outer tube member (11) is configured to be located at the spongybone (1), and wherein the perforating device (4) further includes aperforating means (12), the perforating means (12) being configured tobe movable in said outer tube member (11) in coaxial and/or rotarydirection and includes and/or cooperates with a perforating member (13)for making the hole (5) in the spongy bone (1).
 24. The device accordingto claim 23, wherein the perforating means (12) further includes theinner tube member (15) configured to direct rinsing agent (7) into orout of the hole (5) in the spongy bone (1).
 25. The device according toclaim 24, wherein the outer or inner tube member (11 or 15) is connectedto a vacuum source (9) for sucking rinsing agent (7) through the hole(5) in the spongy bone (1) and out of said hole through the outer tubemember (11).
 26. The device according to claim 1, wherein theperforating device (4) further includes several units for making atleast two holes (5) in the spongy bone (1), wherein the at least twoholes are configured to either extend into each other, or be separatedfrom one another with spongy bone (1) remaining therebetween, andwherein the sponging bone (1) remaining between the at least two holes(5) is penetrated by air and provided with bone substitute and/or bonereinforcing material (3).
 27. The device according to claim 1, whereinthe vacuum source (9) is an injector pump (21) operatable by acompressed medium.
 28. The device according to claim 27, wherein theinjector pump (21) is connected to a compressed-medium device (22) whichis designed as a compressed-air device and is positionable in localitiesin or close to which the vacuum source (9) shall be used.
 29. The deviceaccording to claim 28, wherein the injector pump (21) is connected to acompressed-medium device (22) with commercial gas.
 30. The deviceaccording to claim 28, wherein the injector pump (21) is connected to acompressed-medium device (22) which is configured to operate said pumpwith a compressed-medium pressure of 4.5-8.5 bar.
 31. The deviceaccording to claim 1, wherein the vacuum source (9) is an electricallyoperated vacuum pump.
 32. The device according to claim 1, wherein thevacuum source (9) is a pump operated by gas.
 33. The device according toclaim 1, wherein the vacuum source (9) is operated by hand.
 34. Thedevice according to claim 1, characterized in that the spongy bone (1)is a spongy vertebra (2).
 35. The device according to claim 1, whereinthe spongy bone (1) is a fracture due to osteoporosis.
 36. The deviceaccording to claim 1, wherein the spongy bone (1) is a femoral or kneefracture.
 37. The device according to claim 1, wherein the rinsing agent(7) is a sodium chloride solution.
 38. The device according to claim 1,wherein the rinsing agent (7) contains a detergent.
 39. The deviceaccording to claim 1, wherein the flushing or rinsing device (6)contains the rinsing agent (7), and wherein the rinsing agent (7)contains at least one trombolytic substance.
 40. The device according toclaim 1, wherein flushing or rinsing device (6) contains the rinsingagent (7), and wherein the rinsing agent (7) is distilled water.
 41. Thedevice according to claim 1, further including a device (9 and/or 30)configured to impart pulse like suction and/or insertion movements tothe bone substitute and/or bone reinforcing material (3) into the hole(5) in the spongy bone (1).
 42. The device according to claim 1, furtherincluding a secondary device (9 and/or 30) configured to impartreciprocating suction and/or insertion movements to the bone substituteand/or bone reinforcing material (3) into the hole (5) in the spongybone (1).
 43. The device according to claim 1, further including asecondary device (9 and/or 30) configured to impart pulse like suctionand/or feeding of the rinsing agent (7) through the hole (5) in thespongy bone (1).
 44. The device according to claim 1, further includinga bone substitute and/or bone reinforcing material, wherein the bonesubstitute and/or bone reinforcing material is at least one of a mineralmaterial, a substantially mineral material, a ceramic, and asubstantially ceramic material.
 45. The device according to claim 44,wherein the mineral material or ceramic material is a hardenable mineralor ceramic which can be brought to harden in the spongy bone (1). 46.The device according to claim 45, wherein the mineral material orceramic can be brought to harden by being mixed with a hardening agentsuch a water.
 47. The device according to claim 44, wherein the mineralmaterial or ceramic is selected from the group comprising calciumsulphate-α-hemihydrate, calcium sulphate-β-hemihydrate, calciumsulphate-dihydrate, calcium carbonate, α-tricalcium phosphate,hydroxyapatite, dicalcium phosphate-dihydrate, anhydrous dicalciumphosphate, tetracalcium phosphate, β-tricalcium phosphate, calciumdeficient hydroxyapatite, monocalcium phosphate-monohydrate, monocalciumphosphate, calcium-pyurophosphate, precipitated hydroxyapatite,carbonaceous apatite (dahlite), octacalcium phosphate, amorphous calciumphosphate, oxyapatite, carbonato apatite and calcium aluminate.
 48. Thedevice according to claim 44, wherein an X-ray contrast agent is mixedwith the ceramic material.
 49. The device according to claim 48, whereinthe X-ray contrast agent is water soluble and non-ionic.
 50. The deviceaccording to claim 49, wherein the water soluble, non-ionic X-raycontrast agent is selected from the group comprising iohexol, ioversol,iopamidol, iotrolan, metrizamide, iodecimol, ioglucol, ioglucamide,ioglunide, iogulamide, iomeprol, iopentol, iopromide, iosarcol,iosimide, iotusal, ioxilan, iofrotal and iodecol.
 51. The deviceaccording to claim 1, further including a bone substitute and/or bonereinforcing material (3), the bone substitute and/or bone reinforcingmaterial (3) is a bone cement including a polymer component, and amonomer component, wherein the polymer and monomer harden to bone cementafter mixing with each other and feeding into the hole (5) of the spongybone (1).
 52. The device according to claim 51, wherein the bonesubstitute and/or bone reinforcing material (3) consists of mineraland/or ceramic in combination with polymer material.
 53. A method forproviding spongy bone with bone substitute and/or bone reinforcingmaterial, wherein at least one hole (5) is made in the spongy bone (1),the at least one hole (5) is flushed or rinsed with rinsing agent (7),and a vacuum is generated in the hole (5) for sucking and/orfacilitating insertion or feeding of the bone substitute and/or bonereinforcing material (3) into the hole (5).
 54. The method according toclaim 53, wherein a vacuum is generated in the hole (5) for suckingrinsing agent (7) through said hole (5).
 55. The method according toclaim 53, wherein the rinsing agent (7) is brought to flush tissuematerial and other material away from the sides (5 a) of the hole (5)such that depressions (5 b) are formed therein and that bone substituteand/or bone reinforcing material (3) is brought to penetrate into saiddepressions (5 b).
 56. A Method for providing spongy bone with bonesubstitute and/or bone reinforcing material (3), which is applied orprovided in at least one hole (5) in the spongy bone (1) in which avacuum is generated, wherein the bone substitute and/or bone reinforcingmaterial (3) is brought to pulsate during its application in the spongybone (1).
 57. The method according to claim 56, wherein reciprocatingmovements are imparted to the bone substitute and/or bone reinforcingmaterial (3) during its application in the hole (5) in the spongy bone(1).
 58. A method for providing spongy bone with bone substitute and/orbone reinforcing material (3), which is applied or provided in at leastone hole (5) in the spongy bone (1) in which a vacuum is generated andwherein the hole (5) is flushed or rinsed with rinsing agent (7) beforeapplication therein of the bone substitute and/or bone reinforcingmaterial (3), wherein the rinsing agent (7) is sucked pulsatinglythrough the hole (5) in the spongy bone (1) by generating a pulsatingvacuum in said hole (5).
 59. The device according to claim 39, whereinthe at least one trombolytic substance is chosen from heparin,streptokinase, urokinase, TPA, and other substances dissolving coagulumand thrombi, and mixtures thereof.
 60. The device according to claim 51,wherein the polymer is polymethyl-methacrylate (PMMA)-type, and themonomer is methylmethacrylate (MMA)-type.